A Phase III Study of SKB264 for EGFR Mutant NSCLC Patients

NCT ID: NCT05870319

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 376 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-26
• Study Completion Date: 2026-09-30

Brief Summary

This is a randomized, open-label, multicenter Phase 3 clinical study to evaluate SKB264 monotherapy versus pemetrexed in combination with platinum in subjects with locally advanced or metastatic non-squamous NSCLC with EGFR mutation who have failed to EGFR-TKI therapy.

Detailed Description

This is a randomized, open-label, multicenter Phase 3 clinical study to evaluate SKB264 monotherapy versus pemetrexed in combination with platinum in subjects with locally advanced or metastatic non-squamous NSCLC with EGFR mutation who have failed to EGFR-TKI therapy. The primary objective is to compare the efficacy and safety of SKB264 monotherapy versus pemetrexed in combination with platinum in patients with locally advanced or metastatic non-squamous NSCLC with EGFR mutation who have failed to EGFR-TKI therapy.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SKB264 by IV infusion on Days 1 and 15 of each 4-week cycle;

Group Type: EXPERIMENTAL

SKB264

Intervention Type: DRUG

intravenous (IV) infusion (Q2W)

pemetrexed+ carboplatin or on Day 1 of each 3-week cycle, with 4 cycles chemo

Group Type: ACTIVE_COMPARATOR

Pemetrexed

Intervention Type: DRUG

500 mg/m2 intravenous (IV) infusion (Q3W)

Carboplatin

Intervention Type: DRUG

AUC 5 intravenous (IV) infusion (Q3W) 4cycles

Cisplatin

Intervention Type: DRUG

75 mg/m2 intravenous (IV) infusion (Q3W) 4cycles

Interventions

SKB264

intravenous (IV) infusion (Q2W)

Intervention Type: DRUG

Pemetrexed

500 mg/m2 intravenous (IV) infusion (Q3W)

Intervention Type: DRUG

Carboplatin

AUC 5 intravenous (IV) infusion (Q3W) 4cycles

Intervention Type: DRUG

Cisplatin

75 mg/m2 intravenous (IV) infusion (Q3W) 4cycles

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Males or females aged ≥18 to ≤75 years at the time of signing the ICF;

2. Histologically or cytologically confirmed non-squamous NSCLC and locally advanced (stage IIIB/IIIC) or metastatic (Stage IV) non-squamous NSCLC not amenable to radical surgery and/or radical concurrent/sequential chemoradiotherapy;

3. EGFR-sensitive mutations;

4. Failure of prior EGFR-TKI therapy;

5. At least one measurable target lesion per RECIST 1.1 as assessed by the investigator;

6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;

7. Expected survival ≥12 weeks;

8. Adequate organ and bone marrow function;

9. Female subjects of childbearing potential and male subjects with partners of childbearing potential who use effective medical contraception from the time of signing the informed consent form until 6 months after the last dose;

10. Subjects voluntarily participate in the study, sign the ICF, and will be able to comply with the protocol-specified visits and relevant procedures

Exclusion Criteria

1. Histologically or cytologically confirmed presence of small cell lung cancer, neuroendocrine carcinoma, and carcinosarcoma components or squamous cell carcinoma components of more than 10%;

2. Other malignancies within 3 years prior to the first dose;

3. History of (noninfectious) interstitial lung disease (ILD)/noninfectious pneumonitis requiring steroid therapy and current ILD/noninfectious pneumonitis;

4. Subjects with active chronic inflammatory bowel disease, GI tract obstruction, severe ulcers, perforation gastrointestinal, abdominal abscess, or acute GI tract bleed;

5. Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1 (per NCI CTCAE 5.0) or to the level specified in the eligibility criteria;

6. Subjects with human immunodeficiency virus (HIV) test positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection;

7. Prior TROP2-targeted therapy;

8. Prior treatment with any drug therapy targeting topoisomerase I inhibitor, including antibody-drug conjugates (ADCs);

9. Major surgery within 4 weeks prior to the first dose or expected to require major surgery during the study;

10. Subjects who have received live vaccines within 30 days prior to the first dose, or are scheduled to receive live vaccines during the study;

11. Pregnant or lactating women;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

References

Fang W, Wu L, Meng X, Yao Y, Zuo W, Yao W, Xie Y, Zhang Y, Cui J, Zhang Y, Li X, Zhuang W, Fang J, Wang Q, Jiang W, Li K, Bai Y, Luo Y, Ma F, Yu Y, Zheng W, Liu Z, Yang B, Ma R, Fang Y, Yang R, Jiang L, Hu J, Yang J, Diao Y, Jin X, Ge J, Yang Y, Zhang L. Sacituzumab Tirumotecan in EGFR-TKI-Resistant, EGFR-Mutated Advanced NSCLC. N Engl J Med. 2025 Oct 19. doi: 10.1056/NEJMoa2512071. Online ahead of print.

Reference Type: DERIVED

PMID: 41124220 (View on PubMed)

Other Identifiers

SKB264-Ⅲ-09

Identifier Type: -

Identifier Source: org_study_id